Manager, Cell Therapy Validation Engineering

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose of the Position:

The Manager will lead a team responsible for the qualification lifecycle of a CAR-T facility, including facilities, critical utilities, processing equipment, and quality control laboratory. This role will oversee the commissioning and qualification lifecycle from initial qualifications, change control qualifications, periodic assessment / requalification and decommissioning. This role will engage with the Devens Cell Therapy Facility project team to establish site qualification/validation procedures and ensure seamless transition of qualification activities from project, through startup and into routine operations.

Primary Responsibilities:

• Recruit, develop and lead a high performing team responsible for the qualification lifecycle of the Devens CAR-T facility, including facilities, utilities, processing equipment, analytical instruments and Quality Control Laboratory.
• Provide coaching, mentoring and development of staff. Conducts powerful conversations and provides meaningful and actionable feedback for staff growth and development. Executes all phases of the performance review process with diligence and on time.
• Establishing department goals, tracking and reporting KPIs, and ensures department goals and metrics are meeting or exceeding expectations. Identifies deficiencies, creates and executes action plans to mitigate issues.
• Drives continuous improvements through staff engagement. Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.
• Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Implements and maintains qualification/validation procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Ensures team consistently executes qualification and validation documentation with accuracy, completeness and compliance to BMS standards.
• Champions inspection readiness efforts acts as departmental delegate and SME in both internal and regulatory audits.
• Building and maintaining a training program for cGMP and qualification/validation program. Ensuring team has and maintain the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
• Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Models these behaviors every day.
• Championing a culture of exceptional teamwork and communication across the organization.
• Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.
  
  Education and Experience:
• Bachelor's degree in relevant science or engineering discipline, or equivalent work experience. Advanced degree preferred
• A minimum of 6 years of relevant work experience within pharmaceutical or a similarly regulated industry
• Experience with hiring, coaching and developing staff
• Advanced understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry. Able to act as a resource for colleagues.
• Advanced knowledge of ISPE C&Q guidance and 21 CFR Part 11 compliance
• Experience with Board Of Health (BOH) Inspectors, External Auditors, Corporate and Internal Auditors presenting validation philosophies, strategies and executed testing is preferred.
• Technical writing capability and experience with writing, approving and training staff on SOPs and validation documents
  
  Knowledge Skills and Abilities:
• Proven leadership ability, professionalism and technical competency to represent the department before our customers, regulatory agencies, and management.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment
• Demonstrated ability to lead teams to achieve objectives.
• Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques is preferred.
• Familiarity of lab and manufacturing computer system configuration such as MS Windows client and server technologies including user groups, folder permissions and windows policies preferred
• Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts.
• A working understanding of lean principles is preferred.
• Excellent project management, communication, and technical writing skills are required.
• Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.
• Proficient in MS Office applications
  
  Working Conditions:
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Ability to work in the vicinity of strong magnets

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.